BPX-601 is a modified CAR T-cell therapy being developed by Bellicum to treat solid tumors that produce a protein called prostate stem cell antigen or PSCA.

PSCA is a cancer antigen, a substance that works to stimulate an immune response against it. It is produced by several types of cancer, including those of the bladder, esophagus, stomach, pancreas, and prostate.

How BPX-601 works

BPX-601 is a version of the CAR-T cell therapy, in which T-cells — a type of specialized immune cell — are genetically engineered to produce special receptors known as CARs. Upon administration, these special receptors activate the T-cells, allowing them to recognize and attach to the PSCA antigen and trigger an immune response against cells expressing this antigen.

Unlike standard CARs that depend on antigens to activate and proliferate, BPX-601 contains modified CAR T-cells that do not depend on antigens for survival. In other words, CAR T-cells in BPX-601 have been engineered to improve T-cells’ ability to survive longer in the absence of antigens. According to the company, this modified technology is expected to give physicians greater control over the level and proliferation of cancer-fighting T-cells, which may improve the treatment’s efficacy and safety.

BPX-601 in clinical trials

The feasibility and safety of BPX-601 is currently being investigated in a Phase 1, single center, open-label and non-randomized trial (NCT02744287). The trial’s main goal is to determine the safety of BPX-601 in people diagnosed with pancreatic cancer that cannot be removed with surgery. Other objectives are to investigate the safety of BPX-501 infusion following BPX-601 administration, and the persistence of CAR-T cells over time after a single BPX-501 infusion. BPX-501 is a small molecule that enhances the survival and drives the proliferation of T cells.

This study is currently enrolling about 30 patients at its one site in Dallas; more information is available by clicking on its identification number.

Initial trial results are anticipated by 2018, and the study itself is expected to finish in December 2020.

Preclinical data released by Bellicum indicated that BPX-601 has a robust anti-tumor activity and further enhances the proliferation and persistence of T-cells in comparison to traditional CAR T-cell constructs.


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